UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
_____________
FORM
8-K
_____________
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date of report
(Date of earliest event reported): October 28, 2019
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(212 )
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Item
8.01. Other Events.
On October 28,
2019, TG Therapeutics, Inc. (the “Company”) issued a
press release announcing data from the UNITY-NHL Phase 2b pivotal
trial evaluating umbralisib in patients with relapsed/refractory
follicular lymphoma. A copy of the press release is being filed as
Exhibit 99.1 and incorporated in this Item by
reference.
Item
9.01. Financial Statements And Exhibits.
(d)
Exhibits.
99.1
Press release issued by TG Therapeutics,
Inc., dated October 28, 2019.
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
TG Therapeutics, Inc.
(Registrant)
By: /s/ Sean A. Power
Sean A. Power
Chief Financial Officer
Date: October
28, 2019
- 3
-
Exhibit
99.1
TG Therapeutics Announces Positive Results from the UNITY-NHL Phase
2b Pivotal Trial Evaluating Umbralisib Monotherapy in Patients with
Relapsed/Refractory Follicular Lymphoma
Follicular lymphoma cohort met the primary endpoint of overall
response rate (ORR)
Umbralisib monotherapy appeared to be well tolerated with a safety
profile consistent with previous reports
TG plans to present the data at a future medical conference and
discuss the results with the FDA
Conference call to be held today, Monday, October 28, 2019 at 8:30
AM ET
NEW YORK, Oct. 28, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics,
Inc. (NASDAQ: TGTX), a biopharmaceutical company developing
medicines for patients with B-cell mediated diseases, today
announced that the follicular lymphoma (FL) cohort of the UNITY-NHL
Phase 2b pivotal trial evaluating single agent umbralisib, the
Company’s novel, once daily, PI3K delta inhibitor, met the
primary endpoint of overall response rate (ORR) as determined by
Independent Review Committee (IRC) for all treated patients (n=118)
who have received at least two prior lines of therapy including an
anti-CD20 monoclonal antibody and an alkylating agent. The results
met the Company’s prespecified ORR target of 40-50%.
Importantly, umbralisib monotherapy
appeared to be well tolerated with a safety profile consistent with
previous reports.
Michael S. Weiss, Executive Chairman and Chief Executive Officer of
TG Therapeutics stated, “We are extremely pleased to announce
that the UNITY-NHL follicular lymphoma cohort evaluating umbralisib
monotherapy met the primary endpoint of ORR. There are no fully
approved drugs for patients with follicular lymphoma that have
progressed following two or more prior lines of therapy and we are
excited by the potential to offer a novel treatment for this
underserved population. We look forward to sharing
these results with the FDA and discussing submission opportunities
for accelerated approval of umbralisib in follicular lymphoma."
Mr. Weiss continued, “These are
very exciting times for TG and with two additional major events
targeted to occur over the next several months, including
commencing our first NDA filing for
umbralisib in patients with relapsed/refractory marginal zone
lymphoma and results from our UNITY-CLL Phase 3 trial, we expect
that excitement to continue. Taken together, we see 2020 shaping up
as a pivotal year where we transition from a development-stage
company into a fully-integrated development and commercial
organization.”
ABOUT THE UNITY-NHL PHASE 2b STUDY—FOLLICULAR LYMPHOMA
COHORT
The multicenter, open-label, UNITY-NHL Phase 2b study –
Follicular Lymphoma cohort was designed to evaluate the safety and
efficacy of single agent umbralisib, the Company’s
novel, once daily, PI3K delta inhibitor, in patients with FL who
have received at least two prior lines of therapy, including an
anti-CD20 regimen and an alkylating agent. The primary endpoint is
overall response rate (ORR) as determined by Independent Review
Committee (IRC) assessment. Secondary endpoints include safety,
duration of response, and progression-free survival
(PFS).
The positive ORR outcome announced today was based on 118 FL
patients that received at least one dose of umbralisib and who
previously had received at least two prior lines of therapy,
including an anti-CD20 regimen and an alkylating
agent.
CONFERENCE CALL INFORMATION
The Company will host a conference call today, Monday, October
28, 2019 at 8:30 AM ET to discuss the UNITY-NHL FL news. In
order to participate in the conference call, please call
1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.),
Conference Title: TG Therapeutics Update Call.
A live audio webcast of this call will be available on the Events
page, located within the Investors & Media section, of the
Company's website at www.tgtherapeutics.com.
An audio recording of the conference call will also be available
for replay at www.tgtherapeutics.com,
for a period of 30 days after the call.
ABOUT FOLLICULAR LYMPHOMA
Follicular lymphoma (FL) is typically a slow-growing or indolent
form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes,
making it a B-cell lymphoma. Follicular lymphoma is usually not
considered to be curable, and is a chronic disease. Patients can
live for many years with this form of lymphoma. With an annual
incidence in the United States of approximately 15,000 newly
diagnosed patients1,
FL is the most common indolent lymphoma accounting for
approximately 20 percent of all NHL cases2.
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a biopharmaceutical company focused on the
acquisition, development and commercialization of novel treatments
for B-cell malignancies and autoimmune diseases. Currently, the
company is developing two therapies targeting hematological
malignancies and autoimmune diseases. Ublituximab (TG-1101) is a
novel, glycoengineered monoclonal antibody that targets a specific
and unique epitope on the CD20 antigen found on mature
B-lymphocytes. TG Therapeutics is also developing
umbralisib (TGR-1202), an oral, once-daily inhibitor of PI3K-delta.
Umbralisib uniquely inhibits CK1-epsilon, which may allow it to
overcome certain tolerability issues associated with first
generation PI3K-delta inhibitors. Both ublituximab and umbralisib,
or the combination of which is referred to as "U2", are in Phase 3
clinical development for patients with hematologic malignancies,
with ublituximab also in Phase 3 clinical development for Multiple
Sclerosis. Additionally, the Company has recently brought its
anti-PD-L1 monoclonal antibody, TG-1501, its covalently-bound
Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as
its anti-CD47/CD19 bispecific antibody, TG-1801, into Phase 1
development. TG Therapeutics is headquartered in New
York City.
Cautionary Statement
Some of
the statements included in this press release may be
forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection
of the safe harbor for forward-looking statements contained in the
Private Securities Litigation Reform Act of 1995. In addition
to the risk factors identified from time to time in our reports
filed with the Securities and Exchange Commission, factors
that could cause our actual results to differ materially are the
following: our ability to successfully and cost effectively
complete preclinical and clinical trials; the risk that the
clinical trial results from the UNITY-NHL FL cohort will not be
sufficient to support a filing for approval; the risk that the
positive data from the UNITY-NHL FL cohort will not be reproduced
in future studies or in other cohorts of the UNITY-NHL study; the
risk that umbralisib will not receive accelerated approval based on
data from the UNITY-NHL FL cohort; the risk that duration of
response or progression free survival data from the UNITY-NHL FL
cohort when available will not be positive or supportive of
approval; the risk that safety issues will arise when the safety
data is cleaned and analyzed for the UNITY-NHL FL cohort; the risk
that the differentiated tolerability profile for umbralisib
previously observed in clinical trials will not be reproduced in
the UNITY-NHL study, the UNITY-CLL study or any other on-going
studies; the risk that patients with relapsed/refractory FL or MZL
as studied in UNITY-NHL will not be considered an unmet medical
need by regulatory authorities; the risk that the Company’s
target ORR will not be considered sufficient to establish clinical
efficacy in the opinion of any regulatory authority; the risk that
the Company will not commence an NDA filing for umbralisib in
patients with relapsed/refractory FL or marginal zone lymphoma in
the planned timeframe or at all; the risk that data from the
UNITY-CLL Phase 3 trial will not be available in the planned
timeframe or not be sufficient to support a regulatory filing. Any
forward-looking statements set forth in this press release speak
only as of the date of this press release. We do not undertake to
update any of these forward-looking statements to reflect events or
circumstances that occur after the date hereof. This press release
and prior releases are available at www.tgtherapeutics.com.
The information found on our website is not incorporated by
reference into this press release and is included for reference
purposes only.
CONTACT:
Jenna
Bosco
Senior
Vice President,
Corporate
Communications
TG
Therapeutics, Inc.
Telephone:
212.554.4351
Email:
ir@tgtxinc.com
__________________________________________________________________________________
1
American Cancer Society “Key
Statistics for Non-Hodgkin
Lymphoma”
2
Lymphoma Research Foundation
“Follicular Lymphoma”